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Trial registered on ANZCTR

Trial ID
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fish Oils (Omega 3) in ischaemic stroke
Scientific title
A Randomised, Placebo-Controlled Intervention Trial of Omega-3 PUFA, (Fish Oils), in People with Ischaemic Stroke
Secondary ID [1] 273457 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic Cerebrovascular Disease 288 0
Ischaemic Cerebrovascular Stroke 289 0
Condition category
Condition code
Stroke 325 325 0 0

Study type
Description of intervention(s) / exposure
Participants receive 3 gm of fish oil (containing omega-3 PUFAs) orally for the treatment group Participants are seen at 0 and 12 weeks for clinical assessments, anthropometry, venepuncture for haematological and biochemical analyses, assessment of compliance and the recording of adverse events. In addition, a telephone follow-up visit will be performed at 6 and 11 weeks to ascertain safety data (SAEs) and compliance to study treatment.
Intervention code [1] 203 0
Comparator / control treatment
Placebo (palm and soy oil) for the control group for 12 weeks.
Control group

Primary outcome [1] 380 0
To evaluate the effectiveness of Omega-3 PUFAs in improving lipid profiles
Timepoint [1] 380 0
At 12 weeks
Secondary outcome [1] 844 0
To evaluate the treatment on changes in weight, blood pressure, inflammatory and haemostatic markers of cardiovascular disease, and mood.
Timepoint [1] 844 0
The study will provide efficacy and tolerability data on the study treatment given for a total of 12 weeks.
Secondary outcome [2] 845 0
Lipid profile (TC, LDL-C, HDL-C, TG [primary]; LDL-particle size, Apo B), inflammatory markers (hsC-RP, LFT, FBC, ESR, ferritin), haemostatic clotting (fibrinogen), blood pressure, body mass index (BMI), body weight, waist to hip ratio, mood (GHQ 28-item general health questionnaire) and health-related quality of life (SF-36 item short form questionnaire).
Timepoint [2] 845 0
Will be collected at baseline and 12 weeks.

Key inclusion criteria
1. CT confirmed first-ever or recurrent ischaemic stroke 2. Clinically stable with atheromatous disease history greater than 3 months.
Minimum age
45 Years
Maximum age
Not stated
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Known intolerance or hypersensitivity to fish and /or fish oils. 2. Current use of fish oils (dietary supplements) 3. Known to be pregnant or breast feeding 4. Active disease causing malabsorption.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Identical opaque gelatin capsules will be assigned and presented in identical foil blister packs in sealed numbered envelopes. Sealed master envelopes have been prepared by the blister pack manufacturer and sent directly to the Data and Safety Monitoring Board and to the Chief Executive Officer of FPA Health. The treatment codes will only be broken following completion of the analysis of the primary end point. Therefore, allocation concealment will be maintained until the end of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 2 / Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 137 0
New Zealand
State/province [1] 137 0

Funding & Sponsors
Funding source category [1] 384 0
Government body
Name [1] 384 0
Health Research Council
Address [1] 384 0
Level 3, 110 Stanley Street, Auckland, 1010, New Zealand
Country [1] 384 0
New Zealand
Primary sponsor type
Government body
Health Research Council (New Zealand)
Level 3, 110 Stanley Street, Auckland, 1010, New Zealand
New Zealand
Secondary sponsor category [1] 313 0
Name [1] 313 0
CTRU, The University of Auckland
Address [1] 313 0
Level 4, School of Population Health, Tamaki Campus, University of Auckland, Glen Innes, Auckland 1072
Country [1] 313 0
New Zealand

Ethics approval
Ethics application status
Ethics committee name [1] 1377 0
Ethics committee address [1] 1377 0
Ethics committee country [1] 1377 0
New Zealand
Date submitted for ethics approval [1] 1377 0
Approval date [1] 1377 0
Ethics approval number [1] 1377 0

Brief summary
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 35924 0
Address 35924 0
Country 35924 0
Phone 35924 0
Fax 35924 0
Email 35924 0
Contact person for public queries
Name 9392 0
Dr Colin Howe
Address 9392 0
Clinical Trials Reseach Unit
University of Auckland
Private Bag 92019
Glen Innes Auckland 1
Country 9392 0
New Zealand
Phone 9392 0
+64 9 3737999
Fax 9392 0
+64 9 3731710
Email 9392 0
Contact person for scientific queries
Name 320 0
Dr Colin Howe
Address 320 0
Clinical Trials Reseach Unit
University of Auckland
Private Bag 92019
Glen Innes Auckland 1
Country 320 0
New Zealand
Phone 320 0
+64 9 3737999
Fax 320 0
+64 9 3731710
Email 320 0